HomeChinaHangzhou Byron Medical Technology Co.,LTD

Hangzhou Byron Medical Technology Co.,LTD

China · 杭州 · www.byronmed.com
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 91330110MA280XB24B

This company holds 2 NMPA certificates in China and has registrations in United States, Canada — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
27510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 27 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 27 510(k), 0 PMA
China2 certificates (Class III 0 / II 2 / I 0), as of 2026-09-04
Manufacturer names merged into this page: BYRON MEDICAL INC.

Regulatory identity

Unified social credit code
91330110MA280XB24B
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
13
Annual revenue
RMB 10–30M
Website
www.byronmed.com
Product categories
医用康复器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2016-12-20
Registered capital
CNY 2,000,000
Paid-in capital
CNY 2,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-06-25
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

81986
11988
11989
51991
11992
31994
11997
51998
12000
12004

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20242192122三维步态评估系统Class II
CN浙械注准20202070730平衡功能评估与训练系统Class II
USK040149PSI-TEC PERISTALTIC INFILTRATION PUMP2004-06-03
USK001803ACCELERATOR RECIPROCATING CANNULA2000-08-04
USK981215PSI-TEC LIPOSUCTION ASPIRATOR1998-07-01

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